Wound therapy tubeset system for wound volume estimation

ABSTRACT

A tubeset module includes one or more elements of a negative pressure wound therapy (“NPWT”) system, such as a valve, a calibrated leak, a pressure sensor, etc. The tubeset module may communicate with a controller of the NPWT system via a communications interface provided by the tubeset module. The communication between the tubeset module and the controller may be used to fully automate one or more processes involving the operation of the components of the NPWT system included in the tubeset module, allowing the NPWT system to, e.g. estimate a wound site volume, estimate a volume of fluid to be instilled, monitor wound healing progression, etc. without requiring any user interaction or involvement. The tubeset module may be defined by one or more housing elements. The tubeset module may be incorporated into any of the tubing, fluid canister, wound dressing and/or therapy device housing components of the NPWT system.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of priority to U.S. Provisional Application No. 62/755,035, filed on Nov. 2, 2018, which is incorporated herein by reference in its entirety.

BACKGROUND

The present disclosure relates generally to a wound therapy system, and more particularly to a wound therapy system configured to estimate a volume relative to a wound site.

Negative pressure wound therapy (NPWT) is a type of wound therapy that involves applying a negative pressure to a wound site to promote wound healing. Recent advancements in wound healing with NPWT involve applying topical fluids to wounds to work in combination with NPWT. However, it can be difficult to determine the appropriate volume of instillation fluid to deliver to the wound. Additionally, it can be difficult to accurately monitor and track healing progression of the wound over time. Accordingly, it would be advantageous to provide a system and method that would allow for accurate and reliable estimation of available space at a wound site into which instillation fluid could be delivered and estimation of the healing progression of the wound site over time. Advantageously, such a system and method would additionally allow for such volume determinations to be performed automatically by a controller, with the controller not only being configured to be capable of automatically processing and calculating the volume determinations, but with the controller being additionally configured to automatically actuate any required components of the NPWT system as needed to obtain the requisite data points needed for such calculations. Additionally, such a method and system could advantageously be performed at any stage during the NPWT treatment, and could account for changes in the type or size of removed fluid canister used over the course of the NPWT treatment.

SUMMARY

In one implementation of the present disclosure, a wound therapy system includes a therapy device, tube, and a tubeset module. The therapy device includes a canister configured to collect wound exudate from a wound and a pump fluidly coupled to the canister and configured to draw a negative pressure within the canister. The tubing is attached to and fluidly coupled to the canister. The tubing and the canister define a negative pressure circuit. The tubeset module is in fluid communication with the canister and the tubing. The tubeset module includes a valve, a calibrated leak, and a communications interface. The valve is configured to selectively permit flow within the tubing when in an open configuration and to selectively block flow when in a closed configuration. The calibrated leak is configured to provide fluid communication between a negative pressure circuit defined by the tubing and the canister and an ambient atmosphere. The communications interface is configured to receive communications from a controller. The valve is configured to be actuated to the closed configuration in response to a first communication being received by the tubeset module via the communications interface.

In some embodiments, the valve is configured to be actuated to the open configuration in response to a second communication being received by the tubeset module. The communications interface is configured to receive the communications wirelessly from a controller.

In some embodiments, the calibrated leak is configured to selectively provide fluid communication between the negative pressure circuit and the ambient atmosphere in a first configuration and to block fluid communication between the negative pressure circuit and the ambient atmosphere in a second configuration. The calibrated leak is configured to be actuated to the first configuration in response to a third communication being received by the tubeset module.

In some embodiments, the tubeset module further includes a pressure sensor configured to detect a pressure within the negative pressure circuit. The communication interface is configured to transmit information related to the pressure detected by the pressure sensor to a controller. The system may also include a controller. The first communication is transmitted by the controller in response to the controller receiving the information related to the pressure detected by the pressure sensor from the communications interface.

In some embodiments, the tubeset module is provided in-line with the tubing. In some embodiments, the tubeset module is integrated into the fluid canister. The tubeset module is integrated into a therapy device housing to which the fluid canister is attached. In some embodiments, the tubeset module is defined by a single housing element. Each of the valve, calibrated leak and communications interface are contained within the housing element. The tubeset module is defined by a plurality of housing elements. Each of the valve and the calibrated leak are contained within a separate, distinct housing element.

In one implementation of the present disclosure, a method of operating a wound therapy device is provided. A first end of a fluid tube is operable connected to a fluid canister and a pump of a therapy device. A second end of the fluid tube is operably connected to a wound dressing. A tubeset module including a valve, a calibrated leak and a communications interface is operably connected to a negative pressure circuit defined by the fluid tube and the fluid canister. In response to a first communication being received by the communication interface from a controller computer assembly, the valve is actuated from an open configuration in which fluid communication is provided between the wound dressing and the fluid canister to a closed configuration in which fluid communication between the wound dressing and the fluid canister is blocked.

In some embodiments the actuation of the valve is effectuated by an actuator element contained within a housing element of the tubeset module. The actuation of the valve is effectuated in response to a signal being transmitted from the communication interface to a control input provided on the valve.

In some embodiments the tubeset module further includes a pressure sensor. In some embodiments pressure within the negative pressure circuit is detected by the pressure sensor. Information related to the detected pressure is transmitted using the communications interface to the controller computer assembly. Instructions are transmitted by the controller computer assembly to a pump to initiate the application of negative pressure to the negative pressure circuit in response to the controller computer assembly receiving the information related to the detected pressure from the tubeset module.

In some embodiments the calibrated fluid leak is actuated from a closed configuration in which fluid communication between the negative pressure circuit and an ambient atmosphere is blocked to an open configuration in which fluid communication is provided between the negative pressure circuit and the ambient atmosphere in response to the tubeset module receiving instructions from the computer controller assembly.

In one implementation of the present disclosure a tubeset assembly for a wound therapy system includes a tubeset module and a controller. The tubeset module is configured to be operably connected to a fluid canister and fluid tubing of a wound therapy system. The tubeset module includes a housing, a communications interface, a valve and a power source. The housing has a body extending between a first outlet formed on a first end of the housing and a second outlet formed on a second end of the housing. The communications interface is configured to allow for information to be wirelessly received by the tubeset module. The valve defines a first configuration in which the first outlet and the second outlet are in fluid communication with one another and a second configuration in which fluid communication between the first outlet and the second outlet is blocked. The controller is configured to transmit, via the communications interface, first instructions and second instructions to the tubeset module. In response to receiving the first instructions from the controller, the valve is configured to be actuated to the first configuration. In response to receiving the second instructions from the controller, the valve is configured to be actuated to the second configuration.

In some embodiments, the tubeset module assembly further includes a first tubing adapter attached to the first outlet of the housing and a second tubing adapter attached to the second outlet of the housing. The first adapter and second adapter are configured to provide a fluid-tight attachment with the fluid tubing of a wound therapy device. The tubeset module assembly further includes a calibrated leak providing fluid communication between at least one of the housing first end and the housing second end and an ambient atmosphere through an opening extending through the housing body.

In some embodiments, the tubeset module assembly further includes a third outlet provided on the first end of the housing and a fourth outlet provided on the second end of the housing. The tubeset module assembly further includes adapters attached to each of the first, second, third and fourth outlets of the housing. The adapters are configured to provide a fluid-tight attachment with fluid tubing of a wound therapy device.

In some embodiments, in the first valve configuration, the third outlet and the fourth are in fluid communication. In the first valve configuration, fluid communication is blocked between the first outlet and the third outlet, between the first outlet and the fourth outlet, between the second outlet and the third outlet and between the second outlet and the fourth outlet. In the second valve configuration, fluid communication is provided between the first outlet and the third outlet.

In some embodiments, in the second valve configuration, fluid communication between the first outlet and the fourth outlet is blocked. In the second valve configuration, fluid communication between the third outlet and the fourth outlet is blocked. The valve may be a rotatable valve.

Those skilled in the art will appreciate that the summary is illustrative only and is not intended to be in any way limiting. Other aspects, inventive features, and advantages of the devices and/or processes described herein, as defined solely by the claims, will become apparent in the detailed description set forth herein and taken in conjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a partial block diagram of a negative pressure wound therapy system including a therapy device coupled to a wound dressing via tubing, according to an exemplary embodiment.

FIG. 2 is a block diagram illustrating the negative pressure wound therapy system of FIG. 1 in greater detail, according to an exemplary embodiment.

FIG. 3 is a block diagram illustrating the negative pressure circuit, the removed fluid canister circuit and the wound site circuit of the negative pressure wound therapy system of FIG. 1 in greater detail, according to an exemplary embodiment.

FIG. 4 . is a block diagram illustrating a negative pressure wound therapy system, according to an exemplary embodiment.

FIG. 5 is a flowchart of a method of using a negative pressure wound therapy system, according to an exemplary embodiment.

FIG. 6A is a flowchart of method of instilling an initial quantity of fluid to a wound site using the negative pressure wound therapy system, according to an exemplary embodiment.

FIG. 6B illustrates a negative pressure wound therapy system applied to a desired wound site to be treated, prior to the instillation of an initial volume of fluid to the wound site according to an exemplary embodiment.

FIG. 6C illustrates the negative pressure wound therapy system of FIG. 6B following an application of a first negative pressure to the negative pressure wound therapy system, according to an exemplary embodiment.

FIG. 6D illustrates the negative pressure wound therapy system of FIG. 6C during venting of the negative pressure wound therapy system following the application of the first negative pressure as shown in FIG. 6C, according to an exemplary embodiment.

FIG. 6E illustrates the negative pressure wound therapy system of FIG. 6B following an application of a second negative pressure to the negative pressure wound therapy system, according to an exemplary embodiment.

FIG. 6F illustrates the negative pressure wound therapy system of FIG. 6E during venting of the negative pressure wound therapy system following the application of the second negative pressure as shown in FIG. 6E, according to an exemplary embodiment.

FIG. 6G illustrates the instillation of fluid to the wound site using the wound therapy system of FIG. 6B, according to an exemplary embodiment.

FIG. 7 illustrates a negative pressure wound therapy system applied to a wound site following an initial instillation of fluid to the wound site, according to an exemplary embodiment.

FIG. 8A is a flowchart of method of instilling an additional quantity of fluid to a wound site using the negative pressure wound therapy system of FIG. 7 , according to an exemplary embodiment.

FIG. 8B illustrates the negative pressure wound therapy system of FIG. 7 following an application of a first negative pressure to the negative pressure wound therapy system, according to an exemplary embodiment.

FIG. 8C illustrates the negative pressure wound therapy system of FIG. 8B during venting of the negative pressure wound therapy system following the application of the first negative pressure as shown in FIG. 8B, according to an exemplary embodiment.

FIG. 8D illustrates the negative pressure wound therapy system of FIG. 7 following an application of a second negative pressure to the negative pressure wound therapy system, according to an exemplary embodiment.

FIG. 8E illustrates the negative pressure wound therapy system of FIG. 8D during venting of the negative pressure wound therapy system following the application of the first negative pressure as shown in FIG. 8D, according to an exemplary embodiment.

FIG. 9A is a flowchart of method of instilling an additional quantity of fluid to a wound site to the negative pressure wound therapy system of FIG. 7 , according to an exemplary embodiment.

FIG. 9B illustrates the negative pressure wound therapy system of FIG. 7 following an application of a first negative pressure to the negative pressure wound therapy system, according to an exemplary embodiment.

FIG. 9C illustrates the negative pressure wound therapy system of FIG. 9B during venting of the negative pressure wound therapy system following the application of the first negative pressure as shown in FIG. 9B, according to an exemplary embodiment.

FIG. 9D illustrates the negative pressure wound therapy system of FIG. 7 following an application of a second negative pressure to the negative pressure wound therapy system, according to an exemplary embodiment.

FIG. 9E illustrates the negative pressure wound therapy system of FIG. 9D during venting of the negative pressure wound therapy system following the application of the first negative pressure as shown in FIG. 9D, according to an exemplary embodiment.

FIG. 10A is a flowchart of a method of determining whether sufficient dead space is present in a negative pressure wound therapy system, according to an exemplary embodiment.

FIG. 10B illustrates the negative pressure wound therapy system of FIG. 7 following an application of a first negative pressure to the negative pressure wound therapy system, according to an exemplary embodiment.

FIG. 10C illustrates the negative pressure wound therapy system of FIG. 10B during venting of the negative pressure wound therapy system following the application of the first negative pressure as shown in FIG. 10B, according to an exemplary embodiment.

FIG. 11 is a flowchart of a process for monitoring the healing progression of the wound site over time, according to an exemplary embodiment.

FIG. 12 is a flowchart of a method of instilling an initial quantity of fluid to a wound site using the negative pressure wound therapy system, according to an exemplary embodiment.

FIG. 13 illustrates a negative pressure wound therapy system including a tubeset module, according to an exemplary embodiment.

FIG. 14 illustrates a negative pressure wound therapy system including a tubeset module, according to an exemplary embodiment.

FIG. 15 illustrates a negative pressure wound therapy system including a tubeset module, according to an exemplary embodiment.

FIG. 16A is a block diagram of a negative pressure wound therapy system including a tubeset module, according to an exemplary embodiment.

FIG. 16B illustrates the negative pressure wound therapy system comprising a tubeset module of FIG. 16A, according to an exemplary embodiment.

FIG. 17 is a flowchart of a fully automated method of operating a tubeset module, according to an exemplary embodiment.

DETAILED DESCRIPTION

Overview

Referring generally to the FIGURES, a wound therapy system is shown according to various exemplary embodiments. The wound therapy system may include a therapy device and a wound dressing. The therapy device may include an instillation fluid canister, a removed fluid canister, a valve, a pneumatic pump, an instillation pump, a tubeset module and a controller. The wound dressing can be applied to a patient's skin surrounding a wound. The therapy device can be configured to deliver instillation fluid to the wound and provide negative pressure wound therapy (NPWT) by maintaining the wound at negative pressure. Components of the wound therapy device, the wound dressing, and the wound site form a negative pressure circuit.

The controller can be configured to operate the pneumatic pump, the instillation pump, the tubeset module and/or other controllable components of the therapy device. In some embodiments, the controller estimates the volume of the wound based on a comparison of observed dynamic pressure responses to negative pressure being applied to the entirety of the negative pressure circuit and negative pressure being applied to a selected portion of the negative pressure circuit. Based on the comparison of the observed dynamic responses, the controller may be configured to determine a quantity of instillation fluid to be delivered to the wound site.

The tubeset module comprises one or more elements that are actuatable, controllable or which may otherwise be engaged by the controller, with the selective communication of the controller with the tubeset module being configured to allow the controller to, among other functions, effectuate and monitor various dynamic pressure responses in all of and/or in parts of the negative pressure circuit as needed to estimate the volume of the wound, determine a quantity of instillation fluid to be delivered to the wound site and/or perform any other number of functions that may be related to the use of the NPWT system 100.

According to some embodiments, the volume relative to the wound site determined by the controller may relate to the dead space at the wound site (i.e. the available space within a drape layer applied about the wound site into which instillation fluid may be delivered). In some such embodiments, the controller may be configured to determine a quantity of instillation fluid to be delivered to the wound site based on a predetermined percentage of the calculated dead space volume at the wound site (e.g., 20%, 50%, 80%, etc.). The controller can then operate the tubeset module and instillation pump to deliver the determined volume of instillation fluid to the wound. By basing the quantity of instillation fluid to be delivered to the wound site on a calculated volume of the dead space at the wound site, the negative pressure system may be configured to provide for more efficient and more precise delivery of instillation fluid, which may reduce the risk of leakage resulting from over-delivery of instillation fluid and the risk of ineffective wound site treatment resulting from under-delivery of instillation fluid.

In some embodiments, the controller may additionally, or alternatively, measure and monitor volumes relative to the wound site at a plurality of times during wound treatment, with the controller determining healing progression of the wound site based on changes in the measured volume relative to the wound site over the course of NPWT treatment. By monitoring the healing progression of the wound site, the controller may be configured to alert a user if the healing of the wound site is not progressing as intended or expected. These and other features of the wound therapy system are described in detail below.

Wound Therapy System

Referring now to FIG. 1 , a negative pressure wound therapy (NPWT) system 100 is shown according to an exemplary embodiment. NPWT system 100 is shown to include a therapy device 102 fluidly connected to a wound dressing 112 via tubing 108 and 110. As will be described in more detail below, according to various embodiments a tubeset module 300 may be operably connected to the tubing 108 and/or 110.

According to various embodiments, a wound dressing 112 may be placed on or within the wound site 114 and adhered or sealed to a patient's skin 116 surrounding a wound site 114 using drape layer 117. Several examples of wound dressings 112 which can be used in combination with NPWT system 100 are described in detail in U.S. Pat. No. 7,651,484 granted Jan. 26, 2010, U.S. Pat. No. 8,394,081 granted Mar. 12, 2013, and U.S. patent application Ser. No. 14/087,418 filed Nov. 22, 2013. The entire disclosure of each of these patents and patent applications is incorporated by reference herein.

As illustrated by the block diagram of FIG. 2 , in general the therapy device 102 includes a pneumatic pump 120, an instillation pump 122, a filter 128, and a controller 118. Pneumatic pump 120 can be fluidly coupled to removed fluid canister 106 (e.g., via conduit 136) and can be configured to draw a vacuum within removed fluid canister 106 by pumping air out of removed fluid canister 106. In some embodiments, pneumatic pump 120 is configured to operate in both a forward direction and a reverse direction. For example, pneumatic pump 120 can operate in the forward direction to pump air out of removed fluid canister 106 and decrease the pressure within removed fluid canister 106. Pneumatic pump 120 can operate in the reverse direction to pump air into removed fluid canister 106 and increase the pressure within removed fluid canister 106. Pneumatic pump 120 can be controlled by controller 118, described in greater detail below.

Therapy device 102 can be configured to provide negative pressure wound therapy by reducing the pressure at wound site 114. Therapy device 102 can draw a vacuum at wound site 114 (relative to atmospheric pressure) by removing wound exudate, air, and other fluids from wound site 114. Wound exudate may include fluid that filters from a patient's circulatory system into lesions or areas of inflammation. For example, wound exudate may include water and dissolved solutes such as blood, plasma proteins, white blood cells, platelets, and red blood cells. Other fluids 121 removed from wound site 114 may include instillation fluid 105 previously delivered to wound site 114. Instillation fluid 105 can include, for example, a cleansing fluid, a prescribed fluid, a medicated fluid, an antibiotic fluid, or any other type of fluid which can be delivered to wound site 114 during wound treatment. Instillation fluid 105 may be held in an instillation fluid canister 104 and controllably dispensed to wound site 114 via tubing 108. In some embodiments, instillation fluid canister 104 is detachable from therapy device 102 to allow removed fluid canister 106 to be refilled and replaced as needed.

Instillation pump 122 can be fluidly coupled to instillation fluid canister 104 via upstream instillation tubing 108 a and fluidly coupled to wound dressing 112 via downstream instillation tubing 108 b. Instillation pump 122 can be operated to deliver instillation fluid 105 to wound dressing 112 and wound site 114 by pumping instillation fluid 105 through upstream instillation tubing 108 a and downstream instillation tubing 108 b. Instillation pump 122 can be controlled by controller 118, described in greater detail below. According to some embodiments, an instillation tubing valve 109 valve configured to allow for flow only in the direction from the instillation fluid canister 104 to the wound site 114 (e.g. via a one-way valve or a via valve configured to be selectively switched by a user and/or by the controller 118 to a closed position prior to the application of negative pressure to the wound site 114) may generally be provided at a location along a portion of the downstream instillation tubing 108 b. As will be described in more detail below, according to various embodiments, the instillation tubing valve 109 may be provided as part of the tubeset module 300.

Filter 128 can be positioned between removed fluid canister 106 and pneumatic pump 120 (e.g., along conduit 136) such that the air pumped out of removed fluid canister 106 passes through filter 128. Filter 128 can be configured to prevent liquid or solid particles from entering conduit 136 and reaching pneumatic pump 120. Filter 128 may include, for example, a bacterial filter that is hydrophobic and/or lipophilic such that aqueous and/or oily liquids will bead on the surface of filter 128. Pneumatic pump 120 can be configured to provide sufficient airflow through filter 128 that the pressure drop across filter 128 is not substantial (e.g., such that the pressure drop will not substantially interfere with the application of negative pressure to wound site 114 from therapy device 102).

Removed fluid canister 106 may be a component of therapy device 102 configured to collect wound exudate and other fluids 121 removed from wound site 114. In some embodiments, removed fluid canister 106 is detachable from therapy device 102 to allow removed fluid canister 106 to be emptied and replaced as needed. A lower portion of removed fluid canister 106 may be filled with wound exudate and other fluids 107 removed from wound site 114, whereas an upper portion of removed fluid canister 106 may be filled with air. Therapy device 102 can be configured to draw a vacuum within removed fluid canister 106 by pumping air out of removed fluid canister 106. The reduced pressure within removed fluid canister 106 can be translated to wound dressing 112 and wound site 114 via tubing 110.

As shown in FIG. 1 , disposed along tubing 110 at a location between the removed fluid canister 106 and the wound site 114 is a tubing valve 111 configured to selectively permit and prevent fluid flow between the removed fluid canister 106 and the wound site 114. The tubing valve 111 may be defined by any number of different structures (e.g. spring-biased; duck-bill; clamp; check-valve, etc.) configured to allow for the selective control of fluids through the tubing 110, and may include valves that are configured to be selectively opened and/or closed by a user, in response to a sensed stimulus (e.g. a predetermined threshold pressure), or by the controller 118. As will be described in more detail below, according to various embodiments, the tubing valve 111 may be provided as part of the tubeset module 300.

Referring to the block diagram of FIG. 3 , when the tubing valve 111 is in an open, flow configuration, removed fluid canister 106, tubing 110 (i.e. both upstream tubing portion 110 a and downstream tubing portion 110 b), conduit 136 extending between pneumatic pump 120 and removed fluid canister 106, the portion of downstream instillation tubing 108 b extending between the drape layer 117 and instillation tubing valve 109, and wound site 114 are fluidly connected to define a negative pressure circuit 200. Referring further to FIG. 3 , when the tubing valve 111 is in a closed, no-flow configuration, the removed fluid canister 106, conduit 136 and an upstream tubing portion 110 a of the tubing 110 extending between the removed fluid canister 106 and the tubing valve 111 define a removed fluid canister circuit 202 that is fluidly isolated from a wound site circuit 204 defined by the wound site 114, a downstream tubing portion 110 b of tubing 110 extending between the tubing valve 111, a portion of downstream instillation tubing 108 b extending between the drape layer 117 and instillation tubing valve 109, and the wound site 114. As will be discussed in more detail below, the volumes of the tubing 110, conduit 136, and portion of downstream instillation tubing 108 b extending between the drape layer 117 and instillation tubing valve 109 define known volumes which can be easily subtracted from or otherwise factored into calculations of volume(s) relative to the wound site 114.

Referring again to FIG. 1 , according to some embodiments, also provided along and operably fluidly connected to tubing 110 at a location upstream of tubing valve 111 and downstream of removed fluid canister 106 is a calibrated leak system 113 defined by a vent 113 a formed through an outer wall of the tubing 110, the vent 113 a being selectively closeable by a vent valve 113 b. Also forming a part of calibrated leak system 113 may be a flow detector 113 c configured to measure airflow through the vent 113 a. As will be described in more detail below, calibrated leak system 113 is configured to selectively control and measure airflow between tubing 110 and the ambient environment surrounding therapy device 102. According to various embodiments, calibrated leak system 113 can be selectively opened to allow airflow into tubing 110 at a known, predetermined rate. As will be described in more detail below, according to various embodiments, calibrated leak system 113 may be provided as part of the tubeset module 300.

As will be described in more detail below, when both the vent valve 113 b and the tubing valve 111 are closed, operation of the pneumatic pump 120 may be configured to draw a vacuum in only the removed fluid canister circuit 202 portion of the negative pressure circuit 200 (such as, e.g., illustrated in FIG. 6E). When the vent valve 113 b is closed and the tubing valve 111 is open, operation of the pneumatic pump 120 may be configured to draw a vacuum in the entirety of the negative pressure circuit 200 (such as, e.g., illustrated in FIG. 6C). When the vent valve 113 b is open and the tubing valve 111 is closed, airflow from the environment around therapy device 102 may enter through the vent 113 a of the calibrated leak system 113 and fill the vacuum within the removed fluid canister circuit 202 (such as, e.g., illustrated in FIG. 6F). As illustrated, e.g., by FIG. 6D, when both the vent valve 113 b and the tubing valve 111 are open, airflow from the environment around therapy device 102 may enter through the vent 113 a of the calibrated leak system 113 and fill the vacuum within the entirety of the negative pressure circuit 200. As will be understood, according to various embodiments, the opening and/or closing of the vent valve 113 b and/or tubing valve 111 may be effectuated manually or automatically, e.g., using tubeset module 300.

Although the calibrated leak system 113 has been disclosed as being positioned in-line with a portion of the tubing 110 extending between the wound site 114 and the removed fluid canister 106, according to some embodiments, such as, e.g., illustrated in FIG. 4 , the calibrated leak system 113 may be instead formed in-line with conduit 136. The operation of the calibrated leak system 113 of the embodiment of FIG. 4 is similar to the operation of the calibrated leak system 113 illustrated in FIG. 1 , with the calibrated leak system 113 of FIG. 4 being configured to provide a path through which air from the ambient environment may flow into and fill portions or the entirety of the negative pressure circuit 200 following the creation of a vacuum within a portion or entirety of the negative pressure circuit 200. As will be understood, according to various embodiments, any of the methods or systems illustrated or disclosed herein which incorporate a calibrated leak system 113 embodiment as illustrated in FIG. 1 may be modified with a calibrated leak system 113 embodiment as illustrated in FIG. 4 .

As illustrated by the block diagram of FIG. 2 , according to various embodiments, the controller 118 may be configured to operate various components of therapy device 102. In particular, as will be described in more detail below, according to various embodiments, the controller 118 may be configured to control the various components of the NPWT system 100 to execute one or more volume determination procedures via which, e.g., a quantity of instillation fluid 105 to be delivered to the wound site 114 may be determine, the healing progression of the wound site 114 may be tracked, etc. According to various embodiments, the controller 118 may be configured such that these procedures may be performed with minimal user intervention and/or input.

According to various embodiments, therapy device 102 may include a variety of sensors. For example, in some embodiments, therapy device 102 may include pressure sensor 115 a and/or 115 b located in-line in the upstream tubing portion 110 a and/or downstream tubing portion 110 b, which are configured to measure pressure at the removed fluid canister 106 and/or wound site 114. Pressure measurements recorded by pressure sensor(s) 115 a and/or 115 b can be communicated to controller 118. According to various embodiments, controller 118 may use the pressure measurements from pressure sensor(s) 115 a and/or 115 b as inputs to various pressure testing operations and control operations performed by controller 118. As will be described in more detail below, according to various embodiments, the pressure sensor(s) 115 a and/or 115 b may be provided as part of the tubeset module 300.

In some embodiments, therapy device 102 includes a user interface 126. User interface 126 may include one or more buttons, dials, sliders, keys, or other input devices configured to receive input from a user. User interface 126 may also include one or more display devices (e.g., LEDs, LCD displays, etc.), speakers, tactile feedback devices, or other output devices configured to provide information to a user. User interface 126 can also display alerts generated by controller 118. For example, controller 118 can generate a “no canister” alert if removed fluid canister 106 is not detected.

In some embodiments, therapy device 102 includes a data communications interface 124 (e.g., a USB port, a wireless transceiver, etc.) configured to receive and transmit data. Communications interface 124 may include wired or wireless communications interfaces (e.g., jacks, antennas, transmitters, receivers, transceivers, wire terminals, etc.) for conducting data communications external systems or devices. In various embodiments, the communications may be direct (e.g., local wired or wireless communications) or via a communications network (e.g., a WAN, the Internet, a cellular network, etc.). For example, communications interface 124 can include a USB port or an Ethernet card and port for sending and receiving data via an Ethernet-based communications link or network. In another example, communications interface 124 can include a Wi-Fi transceiver for communicating via a wireless communications network or cellular or mobile phone communications transceivers.

Methods of Use

Referring to FIG. 5 , a flowchart of a method 500 of using NPWT system 100 according to an exemplary embodiment is shown. As will be discussed in more detail with reference to FIGS. 6A-6G, initial set up of the NPWT system 100 and a delivery of an initial amount of instillation fluid 105 to a wound site 114 being treated by the NPWT system 100 occurs at step 502.

As shown at step 504, according to various embodiments, it may be desirable to deliver additional instillation fluid 105 to the wound site 114 following the instillation of an initial amount of instillation fluid 105 to the wound site 114. As will be understood, the determination at step 504 of when and if additional instillation fluid 105 is to be delivered to the wound site 114 may be based on any number of various factors, including e.g. elapsed time from a prior instillation; type of wound site 114; desired course of wound site 114 treatment; sensed conditions related to the wound site 114, etc., and may be decided automatically by the controller 118, or may be based on user input.

If it is determined at step 504 that additional fluid is to be delivered, at step 506 the dead space 119 at the wound site 114 is determined according to any of the methods as will be described below. According to various embodiments (described in more detail below), at step 506, the controller 118 may be configured to determine the dead space 103 at the wound site 114 prior to such delivery of additional instillation fluid 105, irrespective of: whether the quantity of instillation fluid 105 previously instilled to the wound site 114 is known; the presence of non-absorbed instillation fluid 105 and/or wound exudate in the space defined between the wound site 114 and the drape layer 117; whether the volume of any contents 107 in the removed fluid canister 106, the volume of the removed fluid canister 106 itself, and/or the volume of any contents 107 previously emptied from the removed fluid canister 106 are known; whether the removed fluid canister 106 has been replaced with a different-sized removed fluid canister 106 during the course of the NPWT treatment; changes to the shape/size/volume of the wound site 114; etc.

At step 508, the quantity of additional instillation fluid 105 to be delivered to the wound site 114 is calculated. According to various embodiments, the quantity of additional instillation fluid 105 delivered to the wound site 114 may be based on the volume of the dead space determined at step 506. For example, in some embodiments, the controller 118 may calculate the volume of instillation fluid 105 to be delivered to wound site 114 by multiplying the volume if dead space determined at step 506 by a fluid instillation factor. The fluid instillation factor may be equal to or less than one (i.e., between zero and one) such that the volume of instillation fluid 105 delivered to the wound site 114 does not exceed the available space within the drape layer 117 (i.e. dead space), thereby minimizing the risk of inadvertent leakage from the wound dressing 112/drape layer 117. In some embodiments, the fluid instillation factor is between approximately 0.2 and approximately 0.8.

In addition to being used to calculate instillation fluid 105 volumes, in some embodiments, the NPWT system 100 may be additionally, or alternatively, used to monitor and track the progress of healing of the wound site 114 over time. Accordingly, in some embodiments, method 500 may optionally include the step 510 of estimating wound site 114 volume, and using the estimated volume to track healing progress of the wound site 114, discussed in more detail with reference to FIG. 11 below.

In some embodiments, it may be desired to remove instillation fluid 105 previously instilled to a wound site 114 from the wound site 114 at some time following the delivery of the instillation fluid 105 to the wound site 114. Accordingly, it may be advantageous to confirm, prior to instilling instillation fluid 105 to the wound site 114, that the dead space in the removed fluid canister 106 will be sufficient to receive the removed instillation fluid 105 and/or any additional fluid 121 (e.g. wound exudate) from the wound site 114 prior to delivering the additional instillation fluid 105 to the wound site 114. As such, method 500 may optionally include step 512 at which the volume of additional instillation fluid 105 calculated at step 508 is compared to the dead space of the removed fluid canister 106 (measured, e.g., during the determination of dead space at the wound site 114 at step 506), with an alarm being presented to the user at step 514 if the instillation fluid 105 to be delivered exceeds the dead space of the removed fluid canister 106. If the instillation fluid 105 to be delivered does not exceed the dead space of the removed fluid canister 106 (or if step 512 is not included as part of method 500), the calculated instillation fluid 105 is delivered to the wound site 114, with some or all of steps 504, 506, 508, 510, 512, 514, 516 being repeated any number of additional times over the course of the NPWT treatment.

Referring to FIG. 6A a flowchart detailing the steps of a method 600 for an initial set up of NPWT system 100 and for delivery of an initial amount of instillation fluid 105 to a wound site 114 entailed in step 502 of the method 500 of FIG. 5 is shown according to one embodiment. At step 602, a NPWT system 100 (such as, e.g., illustrated in FIG. 1 ) is provided, with the drape layer 117 and wound dressing 112 being positioned at the desired wound site 114 to be treated, as shown, e.g., in FIG. 6B.

Once the set-up of the NPWT system 100 at step 502 is complete, the determination of the dead space 119 available at the wound site 114 into which instillation fluid 105 may be delivered may begin at step 604 with the controller 118 operating the pneumatic pump 120 to establish a first desired negative pressure within the entirety of the negative pressure circuit 200, such as, e.g., illustrated in FIG. 6C.

In embodiments in which the tubing valve 111 comprises a normally-closed pressure sensitive valve that is openable in response to an applied, predetermined threshold negative pressure, the first desired negative pressure generated by the controller 118 at step 604 may be equal to or greater than the predetermined threshold pressure required to open the tubing valve 111, so as to ensure that the vacuum applied by the pneumatic pump 120 is applied across the entirety of the negative pressure circuit 200. In some embodiments, the threshold pressure required to open the tubing valve 111 may be a pressure of approximately negative 125 mmHg, with the controller 118 being configured to apply at step 604 a first negative pressure that is equal to or greater than negative 125 mmHg.

Alternatively, in embodiments in which the opening/closing of the tubing valve 111 is controlled manually or in direct response to a signal from the controller 118 (using, e.g., a tubeset module 300 as described below), the negative pressure delivered at step 604 may generally include any desired range of negative pressures, with step 604 including verification by the user and/or controller that the tubing valve 111 is in an open, flow orientation prior to the negative pressure being applied by the pneumatic pump 120. As illustrated, e.g., in FIG. 6C, according to various embodiments, the instillation tubing valve 109 and the vent valve 113 b may be configured to be set to closed configurations during the application of negative pressure to the negative pressure circuit 200.

As illustrated by FIG. 6D, at step 606, following the attainment of the desired first negative pressure within the negative pressure circuit 200 (as, e.g., measured and reported to the controller 118 by pressure sensor 115 a and/or pressure sensor 115 b), the operation of the pneumatic pump 120 is stopped, and the vent valve 113 b is opened to allow air from the ambient environment surrounding the therapy device 102 to flow through the vent 113 a and into the negative pressure circuit 200. According to various embodiments, the opening of the vent valve 113 b at step 606 may be effectuated manually by a user or in response to instructions from the controller 118 being transmitted to the tubeset module 300. In yet other embodiments, the calibrated leak system 113 may be formed without a vent valve 113 b (i.e. the vent 113 a defines a constant leak within the tubing 110), such that air from the ambient environment surround the therapy device 102 will flow into the negative pressure circuit 200 without requiring any user and/or controller 118 intervention.

As air from the ambient environment flows in to the negative pressure circuit 200, parameters related to the flow of air through the vent 113 a into the negative pressure circuit 200 are monitored (e.g. via flow detector 113 c, pressure sensor 115 a, pressure sensor 115 b, etc.), with the measured parameters subsequently being used by the controller 118 at step 612 to determine the volume of the negative pressure circuit 200. According to various embodiments, the parameters related to the flow of air into the negative pressure circuit 200 may include, e.g., the rate of flow of air into the negative pressure circuit 200 (as measured, e.g., by flow detector 113 c), the duration of time required for pressure within the negative pressure circuit 200 to increase to a predetermined pressure (e.g. ambient pressure) following the opening of the vent 113 a and/or following operation of the pump 120 being ceased, the changing pressure (as, e.g., measured by pressure sensor 115 a and/or pressure sensor 115 b) within the negative pressure circuit 200 as the pressure increases from the negative pressure applied at step 604 to the predetermined pressure, etc.

Once the pressure within the negative pressure circuit 200 has increased to a desired pressure and the measurement of the desired parameters has been completed by the controller 118, the controller 118 may be configured operate pneumatic pump 120 to establish a second desired negative pressure within the removed fluid canister circuit 202 portion of the negative pressure circuit 200 at step 608, such as, e.g., illustrated in FIG. 6E. In embodiments in which the tubing valve 111 comprises a normally-closed pressure sensitive valve that is openable in response to an applied, predetermined threshold negative pressure, the second desired negative pressure generated by the controller 118 at step 608 may be less than the predetermined threshold pressure required to open the tubing valve 111, so as to ensure that the vacuum applied by the pneumatic pump 120 at step 608 is applied across only the removed fluid canister circuit 202 portion of the negative pressure circuit 200. For example, in some embodiments, the threshold negative pressure required to open the tubing valve 111 may be approximately negative 125 mmHg, with the controller 118 being configured to apply a negative pressure at step 608 that is less than negative 125 mmHg, such as, e.g., a pressure of approximately negative 50 mmHg.

Alternatively, in embodiments in which the opening/closing of the tubing valve 111 is controlled manually or in direct response to a signal from the controller 118, the negative pressure delivered at step 608 may generally include any desired range of negative pressures, with step 608 including verification by the user and/or controller that the tubing valve 111 is in a closed, no-flow orientation prior to the negative pressure being applied by the pneumatic pump 120. As will be understood, in such embodiments, the second negative pressure applied by the controller 118 at step 608 to the removed fluid canister circuit 202 may include a pressure that is equal to or different from the negative pressure that is applied by the controller 118 at step 604 to the negative pressure circuit 200. As illustrated, e.g., in FIG. 6E, according to various embodiments, the instillation tubing valve 109 and the vent valve 113 b may be configured to be set to closed configurations (either manually or automatically, e.g., using tubeset module 300) during the application of negative pressure to the removed fluid canister circuit 202 at step 608.

As illustrated by FIG. 6F, at step 610, following the attainment of the desired second negative pressure within the removed fluid canister circuit 202 (as, e.g., measured and reported to the controller 118 by pressure sensor 115 a and/or pressure sensor 115 b), the operation of the pneumatic pump 120 is stopped, and air from the ambient environment surrounding the therapy device 102 is allowed to flow through the vent 113 a and into the removed fluid canister circuit 202. As air from the ambient environment flows into the removed fluid canister circuit 202, parameters related to the flow of air through the vent 113 a and into the removed fluid canister circuit 202 are monitored, with the measured parameters subsequently being used by the controller 118 to calculate the volume of the removed fluid canister circuit 202 at step 612. According to various embodiments, the parameters related to the flow of air into removed fluid canister circuit 202 may include, e.g., the rate of flow of air into the removed fluid canister circuit 202 (as measured, e.g., by flow detector 113 c), the duration of time required for pressure within the removed fluid canister circuit 202 to increase to a predetermined pressure (e.g. ambient pressure) following the opening of the vent 113 a and/or ceasing operation or the pump 120 at step 610, the pressure (as, e.g., measured by pressure sensor 115 a and/or pressure sensor 115 b) within the removed fluid canister circuit 202 as the pressure increases from the negative pressure applied at step 608 to the predetermined pressure; etc.

At step 612, the controller 118 may be configured to determine the volumes of the removed fluid canister circuit 202 and the negative pressure circuit 200 based on the parameters measured at steps 606 and 610. According to some embodiments, the controller 118 may base these volume calculations on stored relationships between various measured parameter values and corresponding volumes. These relationships between measured parameter measurements and corresponding volumes that are stored by the controller 118 may include various functions, models, lookup table, etc., and may be based on pre-existing information input and stored by the controller 118, or on information obtained and processed by the controller 118 during an optional, initial training procedure conducted by the controller 118 prior to the use of the NPWT system 100 to treat wound site 114 (e.g. prior to the initiation of method 500; as part of the initial setup and initial instillation of instillation fluid of step 502; etc.). One non-limiting examples of embodiments of training procedures by which such relationships may be generated by the controller 118 are outlined in related, co-pending U.S. Provisional Application 62/650,132, filed Apr. 17, 2018 and titled WOUND THERAPY SYSTEM WITH WOUND VOLUME ESTIMATION, the entire disclosure of which is incorporated by reference herein.

Using the determined volumes of the removed fluid canister circuit 202 and the negative pressure circuit 200, the controller 118 may determine the volume of the dead space 119 at the wound site 114 (i.e. the portion of the interior space defined between the wound site 114 and the lower surface of the drape layer 117 that is not occupied by the wound dressing 112 and/or any instillation fluid 105/other fluid) by subtracting the volume of the removed fluid canister circuit 202 from the volume of the negative pressure circuit 200. According to various embodiments, the determination of the volume of the dead space 119 at the wound site 114 at step 614 may also include subtracting or otherwise adjusting the calculated difference between the volumes of the removed fluid canister circuit 202 and the negative pressure circuit 200 to account for/factor in the known volumes of the downstream tubing portion 110 b and the portion of the downstream instillation tubing 108 b extending between the drape layer 117 and the instillation tubing valve 109 into the determination of the volume of the dead space 119 at the wound site 114.

At step 614, an initial quantity of instillation fluid 105 that is to be delivered to the wound site 114 is calculated. According to various embodiments, the calculated initial quantity of instillation fluid 105 that is delivered to the wound site 114 may be based on the volume of the dead space 119 calculated by the controller 118 at step 612. For example, in some embodiments, the controller 118 may calculate the initial volume of instillation fluid 105 to be delivered to the wound site 114 by multiplying the volume of dead space 119 calculated at step 612 by a fluid instillation factor. The fluid instillation factor may be equal to or less than one (i.e., between zero and one) such that the volume of instillation fluid 105 delivered to the wound site 114 does not exceed the available space within the drape layer 117 (thereby minimizing inadvertent leakage from the wound dressing 112/drape layer 117. In some embodiments, the fluid instillation factor is between approximately 0.2 and approximately 0.8. However, it is contemplated that the fluid instillation factor can have any value in various alternative embodiments.

As noted previously with reference to step 510, in addition to being used to calculate a quantity of instillation fluid 105 to be delivered during any stage of treatment using NPWT system 100 and under any number of different conditions (e.g. allowing for the calculation of additional instillation fluid 105 to be delivered at step 516 even if the removed fluid canister 106 has been emptied, or entirely replaced with a different sized removed fluid canister 106 during the course of treatment), in some embodiments the NPWT system 100 may be additionally, or alternatively, used to monitor and track the progress of healing of the wound site 114 over time. Accordingly, in some embodiments, at step 616, an initial baseline wound site 114 volume estimate may optionally be determined (via, e.g., a method as described with regards to FIG. 11 below) and stored by the controller 118, which may be used as a reference point against which future wound site 114 volume estimates may be compared to track healing progression of the wound site 114.

For reasons similar to those described with reference to step 512 of the method 500 of FIG. 5 , according to some embodiments, at step 618 the amount of initial instillation fluid 105 that is to be delivered calculated at step 614 may be compared to a determined dead space 103 of the removed fluid canister 106 to determine whether the dead space within the removed fluid canister 106 will be sufficient to collect any fluids 121 from the wound site 114 (including non-absorbed instillation fluid 105) following the delivery of instillation fluid 105 at step 516. As will be understood, in embodiments in which the NPWT system 100 has not been operated prior to the use of the NPWT system 100 at step 602, the volume of the removed fluid canister 106 should be empty, such that the dead space 103 of the removed fluid container 106 should be equal to the volume of the removed fluid canister 106. If the volume of the removed fluid canister 106 is not known and/or if removed fluid 107 is present in the removed fluid canister 106 at step 602, the dead space 103 of the removed fluid container may be calculated by subtracting the known volumes of conduit 136 and the upstream tubing portion 110 a from the volume of the removed fluid canister circuit 202 determined at step 614. Similar to step 514, at step 620 an alarm may be presented to a user if the initial volume of instillation fluid 105 to be delivered calculated at step 614 exceeds the dead space 103 of the removed fluid canister 106. Otherwise, if the volume of the initial instillation fluid 105 to be delivered does not exceed the dead space 103 of the removed fluid canister 106, the calculated instillation fluid 105 is delivered to the wound site 114 at step 622, as shown, e.g., in FIG. 6F.

Referring to FIG. 7 , a NPWT system 100 according to one embodiment is shown at a point in time subsequent to a decision to instill additional instillation fluid 105 to the wound site 114 at step 504 of the method 500 of FIG. 5 , but prior to the determination of wound dead space at the wound site at step 506. As shown in FIG. 7 , at the time immediately preceding the determination of dead space at the wound site 114 at step 506, a quantity of fluid 121 (e.g. non-absorbed instillation fluid 105 from a prior instillation, wound exudate, etc.) may be present in the space between the drape layer 117 and the wound site 114, with the remaining space between the drape layer 117 and the wound site 114 defining an initial dead space 119 a. As also shown in FIG. 7 , according to some embodiments, an initial quantity of removed fluid 107 may be present in the removed fluid canister 106 at the time immediately preceding the start of step 506, with the remaining volume of the removed fluid canister 106 being defined by an initial dead space 103 a. As will be understood, according to some embodiments, no fluid may be present at either the wound site 114 and/or in the removed fluid canister 106 at the time immediately preceding step 506, in which embodiments the quantities of each of the fluid 121 in the wound space and the removed fluid 107 in the removed fluid canister 106 would be equal to zero.

As noted above, a quantity of fluid 121 may be present at the wound site 114 immediately prior to the initiation of step 506. According to some embodiments, it may not be desired and/or required to remove fluid 121 from the wound site (e.g. non-absorbed instillation fluid 105 from prior instillations, wound exudate, etc.) prior to the delivery of additional instillation fluid 105 to the wound site 114 at step 516 of the method 500 of FIG. 5 . Accordingly, in some embodiments of method 500, the additional instillation fluid 105 instilled to the wound site at step 516 may be delivered to the wound site 114 irrespective of any fluid 121 that may be present at the wound site 114.

Referring to FIGS. 8A-8E, one embodiment of a method 800 of determining an amount of dead space at a wound site 114 which may be used at step 506 of the method 500 of FIG. 5 in embodiments in which fluid 121 from the wound site 114 is not removed from the wound site 114 prior to instilling additional instillation fluid 105 is illustrated. In particular, according to the method 800 of FIGS. 8A-8E, as no fluid 121 is displaced from the wound site 114 during the method 800 (i.e. step 506), the final dead space into which the additional instillation fluid 121 will be instilled will be the same initial dead space 119 a at the wound site that is present immediately prior to the initiation of step 506 (i.e. the dead space 119 a shown in FIG. 7 ).

As shown by the flowchart in FIG. 8A, the method 800 of determining dead space is substantially the same as the method 600 of calculating the dead space 119 upon initial instillation of instillation fluid 105 to the wound site 114 at step 502 (which is discussed in more detail with reference to FIGS. 6A-6G). In particular, similar to steps 604 and 606, the method 800 of FIG. 8A also includes steps 802 and 804 (shown, e.g., in FIGS. 8B and 8C, respectively) during which negative pressure is applied to and removed from the negative pressure circuit 200. Similar to steps 608 and 610 of the method 600 of FIG. 6A, the method 800 of FIG. 8 also includes steps 806 and 808 (shown, e.g., in FIGS. 8D and 8E, respectively) during which negative pressure is applied to and removed from the removed fluid canister circuit 202. Also similar to the method 600 of FIG. 6A, in the method 800 of FIGS. 8A-8E, the application and subsequent removal of negative pressure to the negative pressure circuit 200 of steps 802 and 804 may be performed either prior to or after the application and subsequent removal of negative pressure to the removed fluid canister circuit 202 of steps 806 and 808.

As noted above, the method 800 of FIGS. 8A-8E may be performed in substantially the same manner as the method 600 described with references to FIG. 6A above. However, whereas, as described above with reference to the method of FIGS. 6A-6E, according to various embodiments, any range of negative pressures may generally be applied to the negative pressure circuit 200 at step 604 of method 600, the negative pressure applied to the negative pressure circuit 200 at step 802 of the method 800 must be limited to negative pressures that will not result in the fluid 121 at the wound site 114 being displaced into the removed fluid canister 106.

Following the completion of step 808, the controller 118 may be configured to calculate the volume of the dead space 119 a at the wound site 114 (which corresponds to the maximum volume of additional instillation fluid 105 that may be delivered to wound site 114) at step 508 of method 500 of FIG. 5 . More specifically at step 508, after calculating the volumes of the removed fluid canister circuit 202 and the negative pressure circuit 200 based on the parameters measured at steps 804 and 808 (in a manner similar to that described with reference to step 612 of the method 600 of FIGS. 6A-6G), the dead space 119 a at the wound site 114 may be calculated based on subtracting the measured volume of the removed fluid canister circuit 202 from the measured volume of the negative pressure circuit 200, with the volume of the removed fluid canister circuit 202 of the method 800 of FIGS. 8A-8E being defined by the dead space 103 a of the removed fluid canister 106, conduit 136 and upstream tubing portion 110 a; and the volume of the negative pressure circuit 200 being defined by the volume of the removed fluid canister circuit 202 (i.e. dead space 103 a of the removed fluid canister 106, conduit 136 and upstream tubing portion 110 a), the downstream tubing portion 110 b, dead space 119 a of the wound site 114 and the portion of downstream instillation tubing 108 b extending between the drape layer 117 and instillation tubing valve 109.

According to various embodiments, in embodiments of method 500 in which the determination of the volume of the dead space 119 a at the wound site 114 at step 508 is based on measured parameters related to the removed fluid canister circuit 202 and negative pressure circuit 200 obtained using the method 800 of FIGS. 8A-8E, step 508 may also include subtracting or otherwise adjusting the calculated difference between the volumes of the removed fluid canister circuit 202 and the negative pressure circuit 200 to account for/factor in the known volumes of the downstream tubing portion 110 b and the portion of the downstream instillation tubing 108 b extending between the drape layer 117 and the instillation tubing valve 109 into the determination of the volume of the dead space 119 a at the wound site 114.

Although, as described above, in some embodiments of method 500, additional instillation fluid 105 may be delivered at step 516 without first removing any remaining fluid 121 at the wound site 114, according to other embodiments, it may be desirable to remove fluid 121 from the wound site 114 prior to the delivery of additional instillation fluid 105.

Referring to FIGS. 9A-9E, one embodiment of a method 900 of determining an amount of dead space at a wound site 114 which may be used at step 506 of the method 500 of FIG. 5 in embodiments in which it is desired to remove fluid 121 from the wound site 114 prior to instilling additional instillation fluid 105 is illustrated. In particular, according to the method 900 of FIGS. 9A-9E, any fluid 121 initially at the wound site 114 immediately prior to step 506 (e.g. as shown in FIG. 7 ) is displaced from the wound site 114 during the method 900 (i.e. step 506), such the final dead space 119 b into which the additional instillation fluid 121 will be instilled will be greater than the initial dead space 119 a at the wound site that is present immediately prior to the initiation of step 506 by an amount generally corresponding to a volume of the fluid 121 displaced from the wound site 114 to the removed fluid canister 106 during the method 900.

As shown by the flowchart in FIG. 9A, the method 900 of determining dead space is substantially the same as the method 600 of calculating the dead space 119 upon initial instillation of instillation fluid 105 to the wound site 114 at step 502 (discussed in more detail with reference to FIGS. 6A-6G). In particular, similar to steps 604 and 606, the method 900 of FIG. 9A also includes steps 902 and 904 (shown, e.g., in FIGS. 9B and 9C, respectively) during which negative pressure is applied to and removed from the negative pressure circuit 200. Similar to steps 608 and 610 of the method 600 of FIG. 6A, the method 900 of FIG. 9 also includes steps 906 and 908 (shown, e.g., in FIGS. 9D and 9E, respectively) during which negative pressure is applied to and removed from the removed fluid canister circuit 202.

However, unlike the method 600 of FIG. 6A in which the application and subsequent removal of negative pressure to the negative pressure circuit 200 at steps 604 and 608 may be performed either prior to or after the application and subsequent removal of negative pressure to the removed fluid canister circuit 202 of steps 610 and 612, in the method 900 of FIG. 9A, the application and subsequent removal of negative pressure to the negative pressure circuit 200 at steps 902 and 904 is performed prior to the application and subsequent removal of negative pressure to the removed fluid canister circuit 202 of steps 906 and 908. Additionally, whereas, as described above with reference to the method of FIGS. 6A-6E, according to various embodiments, any range of negative pressures may generally be applied to the negative pressure circuit 200 at step 604 of method 600, the negative pressure applied to the negative pressure circuit 200 at step 902 of the method 900 of FIG. 9A must be sufficient to cause the displacement of fluid 121 from the wound site 114 into the removed fluid canister 106.

Following the completion of step 908, the controller 118 may be configured to calculate the volume of the final dead space 119 b at the wound site 114 (which corresponds to the maximum volume of additional instillation fluid 105 that may be delivered to wound site 114) at step 508 of method 500 of FIG. 5 . More specifically at step 508, after calculating the volumes of the removed fluid canister circuit 202 and the negative pressure circuit 200 based on the parameters measured at steps 904 and 908 (in a manner similar to that described with reference to step 612 of the method 600 of FIGS. 6A-6G), the final dead space 119 b at the wound site 114 may be calculated based on subtracting the measured volume of the removed fluid canister circuit 202 from the measured volume of the negative pressure circuit 200, with the volume of the removed fluid canister circuit 202 of the method 800 of FIGS. 9A-9E being defined by the final dead space 103 b of the removed fluid canister 106 (with the final dead space 103 b of the removed fluid canister 106 being generally equal to the difference between an initial dead space 103 a within the removed fluid canister 106 and the volume of fluid 121 displaced into the removed fluid canister 106 from the wound site 114 at step 802, as shown, e.g., in FIG. 9B), conduit 136 and upstream tubing portion 110 a; and the volume of the negative pressure circuit 200 being defined by the volume of the removed fluid canister circuit 202 (i.e. final dead space 103 b of the removed fluid canister 106, conduit 136 and upstream tubing portion 110 a), the downstream tubing portion 110 b, final dead space 119 b of the wound site 114 and the portion of downstream instillation tubing 108 b extending between the drape layer 117 and instillation tubing valve 109.

According to various embodiments, in embodiments of method 500 in which the determination of the volume of the dead space 119 at the wound site 114 at step 508 is based on measured parameters related to the removed fluid canister circuit 202 and negative pressure circuit 200 obtained using the method 900 of FIGS. 9A-9E, step 508 may also include subtracting or otherwise adjusting the calculated difference between the volumes of the removed fluid canister circuit 202 and the negative pressure circuit 200 to account for/factor in the known volumes of the downstream tubing portion 110 b and the portion of the downstream instillation tubing 108 b extending between the drape layer 117 and the instillation tubing valve 109 into the determination of the volume of the dead space 119 a at the wound site 114.

In some embodiments of method 500 of FIG. 5 in which fluid 121 from the wound site 114 is removed prior to the instillation of additional instillation fluid 105 at step 516, it may be desirable to ensure that the initial dead space 103 a in the removed fluid canister 106 immediately prior to beginning the step of determining dead space at the wound site at step 506 is sufficient to hold fluid 121 that will be displaced from the wound site 114 into the removed fluid canister during step 506, so as to avoid the risk of removed fluid canister 106 overflow.

Accordingly, in some embodiments of method 500 in which fluid 121 from the wound site 114 is removed prior to the instillation of any additional instillation fluid 105 at step 516, the method of step 506 of determining dead space at the wound site 114 (e.g., such as described with reference to the method 900 of FIGS. 9A-9E) may include determining whether there is sufficient dead space at the removed fluid canister 106 to hold the fluid 121 from the wound site 114 that may be displaced into the removed fluid canister 106 as part of the method of determining dead space at the wound site 114.

Illustrated in FIGS. 10A-10C is one embodiment of such a method that may be used to minimize the risk of overflow of the removed fluid canister 106 during step 506 in which dead space at the wound site 114 is being determined (e.g., via method 900 as described in FIGS. 9A-9E). At steps 1002 and 1004 (shown in FIGS. 10B and 10C, respectively) negative pressure is applied to and removed from the removed fluid canister circuit 202 to determine the initial dead space 103 a in the removed fluid canister 106 prior to beginning step 506 (e.g. as shown in FIG. 7 ). In general, the steps 1002 and 1004 of the method 1000 of FIGS. 10A-10E may be performed in a manner substantially similar to the manner in which steps 608 and 610 of the method 600 of FIGS. 6A-6G are performed. At step 1006, the volume of the removed fluid canister circuit 202 is calculated based on the parameter measured at step 1004 (in a manner similar to that described with reference to step 612 of the method 600 of FIGS. 6A-6G). Once the volume of the removed fluid canister circuit 202 has been calculated, the known volumes of the conduit 136 and the upstream tubing portion 110 a may be subtracted from the calculated removed fluid canister circuit 202 to determining the volume of the initial dead space 103 a in the removed fluid canister 106 (i.e. the maximum volume of fluid 121 displaced from the wound site 114 that the removed fluid canister 106 may hold).

Once the volume of the initial dead space 103 a has been calculated at step 1006, at step 1008, the controller 118 may be configured to estimate the volume of the fluid 121 at the wound site 114 at the time immediately preceding the determination of dead space at the wound site 114 at step 506. The volume of the fluid 121 at the wound site 114 may be based on any number of different factors and variables such as, e.g., stored values of quantities of instillation fluid 105 previously delivered to the wound site 114, stored values of fluid 121 previously removed from the wound site, elapsed time (e.g. from a prior instillation, a prior removal of fluid 121, etc.), etc., with the controller 118 at step 1008 further being configured to compare this estimated volume of fluid 121 to the initial dead space 103 a calculated at step 1006, alerting the user to empty the removed fluid canister 106 at step 1010 if the controller 118 determines that the estimated fluid 121 volume exceeds the calculated initial dead space 103 a. If the calculated initial dead space 103 a is sufficient to hold the estimated volume fluid 121 from the wound site 114, at step 1012 the controller 118 may be configured to begin the step 506 of determining dead space at the wound site 114, e.g., according to method 900 as described with reference to FIGS. 9A-9E.

As noted above, according to some embodiments of method 500, it may be advantageous to monitor changes in the volume of the wound site 114 to track the progress of the healing of the wound site 114 at an optional step 510.

In general, the volume of the wound site 114 is defined by the entirety of the interior extending between the wound site 114 and the drape layer 117 attached to the skin 116 about the wound site 114. At various points during treatment using the NPWT system 100, located within and defining the volume of the wound site may be any one of, and any combination of: the wound dressing 112, fluid 121, and/or dead space 119. As will be understood, unless the wound dressing 112 is replaced during treatment, the volume of the wound site 114 volume occupied by the wound dressing 112 will generally remain unchanged over the course of treatment, whereas the portion of the wound site 114 volume occupied by the fluid 121 and/or dead space 119 may change with time.

Referring to FIG. 11 , a block diagram illustrating one embodiment of a method 1100 of tracking wound site 114 healing progression which may be used at step 510 of the method 500 of FIG. 5 is illustrated. At step 1102, an initial volume of the wound site 114 is estimated and recorded by the controller 118 at a point in time prior to an initial instillation of instillation fluid 105 to the wound site 114, and may serve as a baseline against which subsequent wound site 114 volume estimates are compared to to track healing progress. According to various embodiments, estimation of the initial volume of the wound site 114 at step 1102 may be performed according to (or as) step 616 of method 600 described with reference to FIGS. 6A-6G.

At step 1104, the estimated volume of the wound site 114 is determined and recorded at one or more additional times during treatment (e.g., once per day) following the estimation of the initial wound site 114 volume at step 1102, with the times at which such one or more wound site 114 volumes are estimated and the values of the determined wound site 114 volume being stored as data points within the memory of therapy device 102 and/or presented to a user as an output of therapy device 102 (e.g., via communications interface 124 or user interface 126). In some embodiments, the estimated wound volume can be plotted as a function of time.

The additional wound site 114 volume estimates determined at one or more additional times over the course of treatment at step 1104 may be estimated according to any number of different processes. For example, according to some embodiments, the wound site 114 volume estimates recorded at step 1104 may be based on the final dead space volume at the wound site 114 calculated, e.g., at step 508 of method 500 and/or using method 900 as described with reference to FIGS. 5 and or 9A-9E, respectively.

As shown at step 510 of FIG. 5 and step 616 of FIG. 6A, according to some embodiments, the wound site 114 volume estimates at steps 1102 and/or steps 1104 may be performed in conjunction with method of delivering of instillation fluid 105 to the wound site 114. However, as will be understood, according to other embodiments the determination of and recording of some, all, or none of the wound site 114 volume estimates at steps 1102 and/or steps 1104 may be performed independent of any delivery of instillation of instillation fluid 105 to the wound site 114.

As additional wound site 114 volume estimates are obtained at steps 1104, at step 1106, changes in the estimated wound site 114 volumes over time may be used to determine healing progression of the wound site 114. For example, step 1106 may include comparing wound site 114 volume estimates obtained at step 1104 to one or more previous estimates of the wound site 114 volume (obtained at either step 1104 or step 1102) to identify a change in the wound site 114 volume. In some embodiments, step 1006 may additionally include determining a rate at which the wound site 114 is healing based on the changes in the estimated wound site 114 volume over time. In some embodiments, step 1106 may include extrapolating or predicting a time at which wound site 114 will be fully healed based on the series of wound site 114 volume estimates stored by the controller 118. For example, step 1106 may include predicting a time at which the estimated wound site 114 volume will reach zero (or another threshold value) based on the initial wound site 114 volume estimate obtained at step 1002 and the series of additional wound site 114 volume estimates obtained at step 1004.

According to some embodiments, instead of, or in addition to, a calibrated leak system 113 being provided which is located upstream of the tubing valve 111, the NPWT system 100 may include a calibrated leak system 113 located downstream of the tubing valve 111. In general, such embodiments in which a calibrated leak system 113 is located downstream of the tubing valve 111 may operate in a manner substantially similar to the various methods described with reference to FIGS. 1-11 . However, in contrast to the step of monitoring the pressure decay within the removed fluid canister circuit 202, determining a volume of the removed fluid canister circuit 202 based on the monitored pressure decay, and subsequently using the determined volume of the removed fluid canister circuit 202 to calculate wound site 114 volume, in the method 1200 of FIG. 12 , pressure decay is instead monitored within the wound site circuit 204, with the determined volume of the wound site circuit 204 subsequently being used to calculate the dead space 103 in the removed fluid canister 106.

For example, referring to FIG. 12 , a flowchart detailing the steps of a method 1200 for an initial set up of NPWT system 100 and delivery of an initial amount of instillation fluid 105 to a wound site 114 is shown according to one embodiment in which a calibrated leak system 113 of the NPWT system 100 is positioned downstream of the tubing valve 111. In general, steps 1202, 1204 and 1206 of the embodiment of the method 1200 of FIG. 12 may be performed in a manner substantially similar to that as described with reference to steps 602, 604 and 606 of the method 600 of FIG. 6A.

At step 1208, the controller 118 is configured to initiate operation of the pump 120 to apply a second negative pressure (which may be equal to or different from the negative pressure applied by the controller 118 at step 1204) to the negative pressure circuit 200. According to various embodiments, the instillation tubing valve 109 and the vent valve 113 b may be configured to be set to closed configurations during the application of negative pressure to the negative pressure circuit 200 at step 1208. In embodiments in which a controller 118 controlled tubeset module 300 is used, the controller 118 may be configured to instruct the tubeset module 300 to effectuate the closing of the instillation tubing valve 109 and/or the vent valve 113 b.

At step 1210, following the attainment of the desired second negative pressure within the negative pressure circuit 200 (as, e.g., measured and reported to the controller 118 by pressure sensor 115 a and/or pressure sensor 115 b), the tubing valve 111 is closed so as to define a wound site circuit 204, the operation of the pneumatic pump 120 is stopped, and air from the ambient environment surrounding the therapy device 102 is allowed to flow through the vent 113 a of the and into the wound site circuit 204. As air from the ambient environment flows into the wound site circuit 204, parameters related to the flow of air through the vent 113 a and into the wound site circuit 204 are monitored, with the measured parameters subsequently being used by the controller 118 to calculate the volume of the wound site circuit 204 at step 1212. According to various embodiments, the parameters related to the flow of air into wound site circuit 204 may include, e.g., the rate of flow of air into the wound site circuit 204 (as measured, e.g., by flow detector 113 c), the duration of time required for pressure within the wound site circuit 204 to increase to a predetermined pressure (e.g. ambient pressure) following the opening of the vent 113 a and/or ceasing operation or the pump 120 at step 1210, the pressure (as, e.g., measured by pressure sensor 115 b) within the wound site circuit 204 as the pressure increases from the negative pressure applied at step 1208 to the predetermined pressure; etc.

At step 1212, the controller 118 may be configured to determine the volume of the wound site circuit 204 based on the parameters measured during step 1208. According to some embodiments, the controller 118 may base this wound site circuit 204 volume calculation on stored relationships between various measured parameter values and corresponding volumes. These relationships between measured parameter measurements and corresponding volumes that are stored by the controller 118 may include various functions, models, lookup table, etc., and may be based on pre-existing information input and stored by the controller 118, or on information obtained and processed by the controller 118 during an optional, initial training procedure conducted by the controller 118 prior to the use of the NPWT system 100 to treat wound site 114 (e.g. prior to the initiation of method 500; as part of the initial setup and initial instillation of instillation fluid of step 502; etc.). One non-limiting examples of embodiments of training procedures by which such relationships may be generated by the controller 118 are outlined in related, co-pending U.S. Provisional Application 62/650,132, filed Apr. 17, 2018 and titled WOUND THERAPY SYSTEM WITH WOUND VOLUME ESTIMATION, the entire disclosure of which is incorporated by reference herein.

Using the determined volume of the wound site circuit 204, the controller 118 may determine the volume of the dead space 119 at the wound site 114 (i.e. the portion of the interior space defined between the wound site 114 and the lower surface of the drape layer 117 that is not occupied by the wound dressing 112 and/or any instillation fluid 105/other fluid) by subtracting or otherwise adjusting the calculated volume of the wound site circuit 204 to account for/factor in the known volumes of the downstream tubing portion 110 b and the portion of the downstream instillation tubing 108 b extending between the drape layer 117 and the instillation tubing valve 109 into the determination of the volume of the dead space 119 at the wound site 114.

At step 1214, an initial quantity of instillation fluid 105 that is to be delivered to the wound site 114 is calculated. According to various embodiments, the calculated initial quantity of instillation fluid 105 that is delivered to the wound site 114 may be based on the volume of the dead space 119 calculated by the controller 118 at step 1212. For example, in some embodiments, the controller 118 may calculate the initial volume of instillation fluid 105 to be delivered to the wound site 114 by multiplying the volume of dead space 119 calculated at step 1212 by a fluid instillation factor. The fluid instillation factor may be equal to or less than one (i.e., between zero and one) such that the volume of instillation fluid 105 delivered to the wound site 114 does not exceed the available space within the drape layer 117 (thereby minimizing inadvertent leakage from the wound dressing 112/drape layer 117. In some embodiments, the fluid instillation factor is between approximately 0.2 and approximately 0.8. However, it is contemplated that the fluid instillation factor can have any value in various alternative embodiments.

As noted previously with reference to step 510, in addition to being used to calculate a quantity of instillation fluid 105 to be delivered during any stage of treatment using NPWT system 100 and under any number of different conditions (e.g. allowing for the calculation of additional instillation fluid 105 to be delivered at step 516 even if the removed fluid canister 106 has been emptied, or entirely replaced with a different sized removed fluid canister 106 during the course of treatment), in some embodiments the NPWT system 100 may be additionally, or alternatively, used to monitor and track the progress of healing of the wound site 114 over time. Accordingly, in some embodiments, at step 1216, an initial baseline wound site 114 volume estimate may optionally be determined (via, e.g., a method as described with regards to FIG. 11 ) and stored by the controller 118, which may be used as a reference point against which future wound site 114 volume estimates may be compared to track healing progression of the wound site 114.

At step 1218 the dead space 103 of the removed fluid canister 106 may be calculated to determine whether the dead space within the removed fluid canister 106 will be sufficient to collect any fluids 121 from the wound site 114 (including non-absorbed instillation fluid 105) following the delivery of instillation fluid 105 at step 516. As will be understood, in embodiments in which the NPWT system 100 has not been operated prior to the use of the NPWT system 100 at step 1202, the volume of the removed fluid canister 106 should be empty, such that the dead space 103 of the removed fluid container 106 should be equal to the volume of the removed fluid canister 106.

The dead space 103 of the removed fluid container may be calculated by subtracting the known volumes of conduit 136 and the upstream tubing portion 110 a from a volume of the removed fluid canister circuit 202 determined by subtracting the volume of the wound site circuit 204 calculated at step 1212 from a determined volume of the negative pressure circuit 200. As will be understood, the volume of the negative pressure circuit 200 may be determined in a manner similar to the method via which the volume of the wound site circuit 204 is determined at step 1212.

Similar to step 514, at step 1220 an alarm may be presented to a user if the initial volume of instillation fluid 105 to be delivered calculated at step 1214 exceeds the dead space 103 of the removed fluid canister 106. Otherwise, if the volume of the initial instillation fluid 105 to be delivered does not exceed the dead space 103 of the removed fluid canister 106, the calculated instillation fluid 105 is delivered to the wound site 114 at step 1222.

As will be understood, in some NPWT system 100 embodiments in which a calibrated leak system 113 is provided both upstream and downstream of the tubing valve 111, the NPWT system 100 may be operated to estimate wound site 114 volume and/or estimate dead space 103 at the removed fluid canister 106 according to a method that is the same as or similar to the method 600 of FIG. 6A or a method that is the same as or similar to the method 1200 of FIG. 12 .

In other embodiments of NPWT system 100 in which both an upstream and downstream calibrated leak system 113 are provided, the NPWT system 100 may be operated to estimate wound site 114 volume and/or estimate dead space 103 at the removed fluid canister 106 according to a method that is the same as or similar to the method 600 of FIG. 6A and a method that is the same as or similar to the method 1200 of FIG. 12 . For example, according to some embodiments, a modified method of operating a NPWT system 100 having both upstream and downstream calibrated leak systems 113 may include the steps of: monitoring pressure decay within the negative pressure circuit 200 (such as, e.g., described with reference to step 606 of the method 600 of FIG. 6 and/or step 1206 of the method 1200 of FIG. 12 ); monitoring pressure decay within the removed fluid canister circuit 202 (such as, e.g., described with reference to step 610 of the method 600 of FIG. 6 ); and monitoring pressure decay within the wound site circuit 204 (such as, e.g., described with reference to step 1210 of the method 1200 of FIG. 12 ).

In such embodiments, the determination of wound site 114 volume based on direct measurement (e.g. using the method 1200 of FIG. 12 ) may be compared to wound site 114 volume calculated based on indirect measurement (e.g. using the method 600 of FIG. 6A) and the determination of dead space 103 at the removed fluid canister 106 based on direct measurement (e.g. using the method 600 of FIG. 6A) may be compared to dead space 103 volume calculated based on indirect measurement (e.g. using the method 1200 of FIG. 12 ). The controller 118 in such embodiments may be configured to generate an alarm or alert in response to a discrepancy between the direct and indirect measurements of wound site 114 volume and/or dead space 103 at the removed fluid canister 106. By providing such redundancy to the wound site 114 and/or removed fluid canister 106 dead space 103 calculations, such embodiments may be configured to allow the NPWT system 100 to provide more accurate and reliable results.

As will be understood, according to various embodiments, the controller 118 may be programmed to allow the NPWT system 100 to determine volume relative to the wound site 114 using any or all of the methods described herein. Accordingly, while in some embodiments the controller 118 may optionally be preprogrammed to automatically determine a volume of instillation fluid 105 to be delivered according to a particular method (e.g. the method 900 embodiment illustrated in FIGS. 9A-9E), the controller 118 may optionally also allow a user to select any of the other modes of calculating a volume relative to the wound site 114 based on whether the user desires to, e.g.: remove fluid 121 from the wound site 114 prior to instillation of additional instillation fluid 105; verify sufficient dead space 103 a in the removed fluid canister 106 prior to determining the dead space at the wound site 114; verify sufficient dead space 103 b in the removed fluid canister 106 prior to the instillation of a calculated quantity of additional instillation fluid 105 to be delivered to the wound site 114; monitor changes in the wound site 114 volume to track healing progression; etc.

Tubeset Module

Although in some arrangements, some or all of the calibrated leak system 113, tubing valve 111 and/or the instillation tubing valve 109, or other NPWT system 100 components may be configured to be manually operated/actuated/utilized by a user, as noted above, according to various embodiments, some or all of these components may alternatively be configured to be operated/actuated/utilized by the controller 118, without requiring any user assistance to do so. In such a manner, implementation of the system for/method of determining a volume of instillation fluid to be delivered to a wound site, estimating a volume of a wound, monitoring healing progression of a wound, and/or other use of the NPWT system 100 may be fully automated using the controller 118, allowing for easier use of the NPWT system 100.

By providing the NPWT system 100 with an automated manner via which controller 118 may control or otherwise interact with one or more of the calibrated leak system 113, tubing valve 111, instillation tubing valve 109, and/or other component(s) of the NPWT system 100, the tubeset module 300 may increase the accuracy of the NPWT system 100. For example, in light of the ability of the controller 118 to utilize the tubeset module 300 to independently actuate (i.e. without user intervention) the operation of the calibrated leak system 113, the tubing valve 111 and/or the instillation tubing valve 109 elements, the controller 118 may be configured to increase the rate at which data related to instillation fluid volume estimation, wound site volume estimation, wound site 114 healing progression monitoring, and/or other functions of the NPWT system 100 is gathered. By increasing the data points used to provide such information, the reliability of the information provided by the controller 118 may thereby be increased. Similarly, the obviation or minimization of user involvement provided by the tubeset module 300 may facilitate (and thereby increase the likelihood of) the usage of a dual calibrated leak system 113 arrangement as described with reference to FIG. 12 above, thus also increasing the reliability of the NPWT system 100.

In general, the tubeset module 300 comprises a housing element 304 containing a power source 301, a communications interface 302, and one or more actuatable elements 303 configured to be controlled by the controller 118. In some embodiments, the tubeset module 300 may optionally also comprise one or more additional non-actuatable elements 305, such as, e.g., pressure sensor 115 a and/or pressure sensor 115 b. According to embodiments in which calibrated leak system 113 is not defined by a vent valve 113 b and only comprises a non-actuatable vent 113 a, the non-actuatable element(s) 305 may comprise such a calibrated leak system 113 formed without a vent valve 113 b.

As will be understood, according to some embodiments, some or all of the actuatable elements 303 may be configured so as to be self-actuating. In some such embodiments, the actuatable element 303 may comprise an internal actuator that is in operably connected (via a wired, wireless, or any other type of connection) to the power source 301 and/or communications interface 302 of the tubeset module 300, via which instructions received from the controller 118 and/or power are relayed to the actuator of the actuatable element 303. In other such embodiments, such self-actuation actuatable element 303 may individually comprise one or both of a power source and/or communications interface (in addition to the power source 301 and/or communications interface 302 of the tubeset module). In such embodiments, the instructions from the controller 118 may be received directly by the communication interface of the actuatable element 303 from the controller, or may be received indirectly by the communication interface of the actuatable element 303 from the communication interface 302 of the tubeset module 300. In other embodiments, some or all of the actuatable elements 303 may be configured to be actuated by any number of different types of, or combinations of known actuators that are contained by the housing element 304, with the actuators of the housing element 304 being configured to effectuate actuation of the one or more actuatable elements 303 in response to instructions received from the controller 118.

The power source 301 may comprise any number of, and combination of, sources of energy that are configured to supply sufficient energy to the communications interface 302, actuatable element(s) 303 and/or non-actuatable elements 305 contained by the housing element 304 as required for operation of the NPWT system 100. In some embodiments in which some or all of the tubeset module 300 is integrated into the therapy device 102, the power provided by the power source 301 of the housing element 304 may comprise a power source of the therapy device 102.

The communications interface 302 may comprise any number of, and combination of, wired and/or wireless connections via which the tubeset module 300 may receive communications (such as, e.g., actuation signals) from the controller 118. According to some embodiments, the communications interface 302 may optionally also be configured to send information to and/or receive information from the controller 118, other tubeset module 300 housing elements 304 (such as, e.g., information regarding the status of the one or more actuatable elements 303 and/or non-actuatable elements 305 of the tubeset module 300), and/or other sources. In some embodiments in which some or all of the tubeset module 300 is integrated into the therapy device 102, the communications interface 302 of the housing element 304 may be defined by a portion of a communications interface of the therapy device 102.

According to some arrangements, tubeset module 300 may be defined by a single housing element 304, with each of actuatable elements 303 (e.g. upstream and/or downstream calibrated leak system 113, tubing valve 111 and/or the instillation tubing valve 109, etc.) and/or non-actuatable elements 305 that are to be controlled/utilized by the controller 118 forming a part of the single, integral housing element 304. In other embodiments, the tubeset module 300 may be defined by a plurality of separate and distinct housing elements 304, with each housing element 304 formed with one or more of the various actuatable elements 303 and/or non-actuatable element 305 that are to be controlled/utilized by the controller 118.

According to various arrangements, the one or more housing elements 304 defining the tubeset module 300 may be provided as a separate, discrete, individual component of the NPWT system 100, which may subsequently be attached to or otherwise incorporated into one or more of the other components of a new or existing NPWT system 100. In other arrangements, some or all of the one or more housing elements 304 defining the tubeset module 300 may be provided as an integrated part of one or more of the other components of the NPWT system 100.

For example, in some arrangements, some or the entirety of the tubeset module 300 may be integrated into the wound dressing 112, with the portion of the tubeset module 300 provided with the wound dressing 112 being configured to be removed from the NPWT system 100 with the removal of the wound dressing 112. Upon removal of the integrated wound dressing 112/tubeset module 300, the entire wound dressing 112/tubeset module 300 may be disposed of. Alternatively, the tubeset module 300 may be removed from the wound dressing 112 prior to disposal of the wound dressing 112 and optionally reused with another wound dressing 112 and/or other NPWT system 100 component.

In other arrangements, some or the entirety of the tubeset module 300 may be integrated into the removed fluid canister 106, with the portion of the tubeset module 300 provided with the removed fluid canister 106 being removed from the NPWT system 100 with the removal of the of the removed fluid canister 106 from the NPWT system 100. In some such embodiments, the tubeset module 300 may be monolithically formed with the removed fluid canister 106, while in other embodiments; the tubeset module 300 may be non-integrally formed with the removed fluid canister 106.

According to another arrangement, the tubeset module 300 may be configured to be integrated in-line with one or both of the tubing 108 and/or 110. In such embodiments, attachment adapters 400 may be provided on one or both of the tubeset module 300 and/or tubing 108 and/or 110 to facilitate a fluid tight attachment of the tubeset module 300 to the tubing 108 and/or 110. According to some embodiments, the attachment adapters 400 may be provided on the tubeset module 300, with the attachment adapters 400 being configured to be able to form a fluid tight attachment directly with one or both of the tubing 108 and/or 110, allowing NPWT systems formed without a tubeset module 300 and/or calibrated leak system 113, tubing valve 111 and/or the instillation tubing valve 109 to be retrofitted with a tubeset module 300 so as to provide a NPWT system 100 as disclosed herein.

In some arrangements, some or the entirety of the tubeset module 300 may be integrated into the housing of the therapy device 102. In such embodiments, the efficiency of using the NPWT system 100 may be increased, as by incorporating a tubeset module 300 including some or all of the calibrated leak system 113, tubing valve 111 and/or the instillation tubing valve 109 into the housing of the therapy device 102, the time to setup the NPWT system 100 may be reduced as compared to the time that would otherwise be required to setup up a NPWT system 100 in which some or all of the calibrated leak system 113, tubing valve 111 and/or instillation tubing valve 109 were provided as separate and discrete components of the NPWT system 100. Additionally, by incorporating the tubeset module 300 into the housing of the therapy device 102, a NPWT system 100 as described herein may be provided irrespective of the particular tubing, removed fluid canister, wound dressing, or other component(s) that are provided to define a NPWT system 100 for treatment of a wound site 114.

Referring to FIGS. 13-16 , various embodiments of a tubeset module 300 configured to allow for partially or fully automated control of the NPWT system 100 using the controller 118 are shown. As will be understood, although reference has been made to the controller 118 being provided as part of the therapy device 102, it is to be understood that, according to various arrangements, the controller 118 may be provided separate and remote from the therapy device 102 and/or NPWT system 100 (e.g., by a remote medical provider). In such embodiments, the remotely provided controller 118 may be configured to communicate directly with the tubeset module 300 and/or indirectly with the tubeset module 300 via a communications interface provided by the therapy device 102.

As illustrated by the NPWT system 100 embodiment of FIG. 13 , in some arrangements, the tubeset module 300 is provided as a single, integrated housing element 304 containing actuatable elements 303 comprising a calibrated leak system 113, a tubing valve 111 and an optional instillation tubing valve 109. According to some embodiments, one or both of the tubing valve 111 and the optionally provided instillation tubing valve 109 may comprise the same or distinct clamps. As shown in FIG. 13 , also contained within the housing element 304 is a power source 301 configured to actuate the actuatable element 303 in response to instructions being received from the controller 118 via the communications interface 302.

Although in the embodiment illustrated in FIG. 13 a single, integral tubeset module 300 is shown as being in-line with both tubing 108 and tubing 110, according to other arrangements (now shown) it is to be understood that a first housing element 304 comprising the calibrated leak system 113 and a tubing valve 111 may be provided in-line with tubing 110, while an optional, second housing element 304 comprising instillation tubing valve 109 may be provided in-line with tubing 110.

As illustrated by the NPWT system 100 of FIG. 13 , in some embodiments, the tubeset module 300 may be formed integrally with upstream tubing portion 110 a and/or upstream instillation tubing 108 a. According to some such embodiments, the upstream tubing portion 110 a and/or upstream instillation tubing 108 a with which the tubeset module 300 is integrally formed may in turn be formed integrally with the therapy device 102. In such embodiments, the tubeset module 300 is configured to be removably attached to the downstream tubing portion 110 b and/or downstream instillation tubing 108 b formed integral with the wound dressing 112, such that following use of the NPWT system 100 with a first wound dressing 112, the therapy device 102 with integrated upstream tubing portion 110 a and/or upstream instillation tubing 108 a and tubeset module 300 may be reused with a new, second wound dressing 112. In other embodiments, such as, e.g., illustrated by the NPWT system 100 of FIG. 14 , some or all of the tubeset module 300 may alternatively be formed integrally with the wound dressing 112, with the tubeset module 300 being configured to be removed from the NPWT system 100 with the removal of the wound dressing 112.

Referring to the NPWT system 100 of FIG. 15 , according to some embodiments, the tubeset module 300 may comprise a first housing element 304 containing a calibrated leak system 113 and an optional instillation tubing valve 109, pressure sensor 115 a and/or pressure sensor 119 positioned in-line with the tubing 108 and/or 110. A second housing element 304 comprising a tubing valve 111 may be spaced from the first housing element 304. As shown in FIG. 14 , according to some arrangements, the second housing element 304 may be integrated into the removed fluid canister 106. In other embodiments, the second housing element 304 may alternatively be incorporated into the therapy device 102, or may be provided at a second location in-line with the tubing 110.

Referring to FIG. 16A, a block diagram of a NPWT system 100 according one embodiment is shown. As illustrated by the NPWT system 100 of FIG. 16A, according to some embodiments, fluid communication between some or all of the negative pressure circuit 200 and the ambient environment may be provided by a purge valve system 450 provided along the instillation tubing 108 as an alternative to, or in addition to, calibrated leak 113. According to various embodiments, the purge valve system 450 may comprise a structure similar to that of calibrated leak system 113 (including calibrated leak system 113 embodiments comprising any combination of vent 113 a, vent valve 113 b and/or flow detector 113 c components).

As also illustrated by FIG. 16A, in such NPWT system 100 embodiments, the tubing valve 111 and/or instillation tubing valve 109 may be replaced by a valve assembly 460 that is fluidly attached to the tubing 110 at a junction between the upstream tubing portion 110 a and downstream tubing portion 110 b and that is attached to the instillation tubing assembly at a junction between the upstream tubing 108 a and downstream tubing 108 b, and which is actuatable to a variety of positions. In a first position, the valve assembly 460 may permit fluid flow from the pneumatic pump 120 to the wound site 114 via tubing 110 and from the instillation pump 104 to the wound site 114 via instillation tubing 108. In a second position, the valve assembly 460 may permit fluid flow from the pneumatic pump 120 to the wound site 114 via tubing 110 while blocking fluid flow from the instillation pump 104 to the wound site 114 via instillation tubing 108. In a third position, the valve assembly 460 may block fluid flow from the pneumatic pump 120 to the wound site 114 via tubing 110 while permitting flow from the instillation pump 104 to the wound site 114 via instillation tubing 108. In a fourth position, the valve assembly 460 may fluidly connect the upstream tubing portion 110 a with the upstream instillation tubing 108 a, resulting in the isolation of the downstream tubing portion 110 b, the downstream tubing 108, and the wound dressing 112 from the remained of the therapy device 102.

When in the first configuration, the valve assembly 460 defines a negative pressure circuit 200 is defined by the tubing 136, the fluid canister 106, the tubing 110, the wound site 114 and the portion of the instillation tubing extending between the wound site 114 and the purge valve 450. When in the fourth configuration, the valve assembly 460 defines a removed fluid canister circuit 202 is defined by the tubing 136, the fluid canister 106, the upstream tubing portion 110 a, and the portion of the upstream tubing 108 a extending between the valve assembly 460 and the purge valve 450 and a wound site circuit 204 defined by the downstream tubing portion 110 b, the wound site 114, and the downstream tubing 108 b.

As will be understood, the valve assembly 460 and the purge valve 450 of the NPWT system 100 of FIG. 16A may be operated in a manner similar to the operation of the tubing valve 111, calibrated leak, and/or instillation tubing valve 109 as described with reference to any of the methods described herein for determining wound site volume, estimating a volume of fluid to be instilled, monitoring wound healing progression, or performing any other functions using the NPWT system 100.

Referring to FIG. 16B, a tubeset module 300 configured for used with a NPWT system 100 incorporating a purge valve 450 (such as, e.g. shown in FIG. 16A) is shown according to one embodiment. As illustrated by FIG. 16B embodiments in which the purge valve 450 is provided as a discrete component of the therapy device 112 capable of being automatically actuated by the controller 118, the tubeset module 300 may comprise only a single actuatable element 303, defined by valve assembly 460. As will be understood, in other embodiments, (such as, e.g. where the purge valve 450 provided as part of the therapy device is not automatically actuatable by the controller 118), the purge valve 450 may be provided as a part of a tubeset module 300 that is partially or entirely integrated into the therapy device 112.

Although in the NPWT system 100 embodiment illustrated in FIG. 16A the pure valve 450 is illustrated as being provided as part of the therapy device 112, according to other embodiments, the purge valve 450 may be alternatively, or additionally, provided as a part of the upstream tubing 108 a. In such embodiments, the purge valve 450 may accordingly be provided as an actuatable element 303 of the tubeset module 300.

As will be understood, the controller 118 may be configured to effectuate any number of different operations using the NPWT system 100 based on the selective, fully automated actuation of/interaction with some or all of the actuatable elements 303 and/or non-actuatable elements 305 of a tubeset module 300 according to any number of different methods and protocols. According to various embodiments, the order and/or combination of instructions transmitted by controller 118 to the tubeset module 300 and/or the information received by the controller 118 from the tubeset module 300 may be configured to automatically operate the tubeset module 300 in a manner that allows the controller 118 to automatically effectuate one or more of the methods 500, 600, 800, 900, 1000, 1100, 1200, etc. described herein.

Represented in FIG. 17 is one method 1700 via which the controller 118 may utilize a tubeset module 300 containing actuatable elements 303 comprising a tubing valve 111, instillation tubing valve 109, and calibrated leak system 113 and non-actuatable element(s) 305 comprising one or both of pressure sensor 115 a and/or pressure sensor 115 b to automatically control the NPWT system 100 to determine dead space 119 at a wound site 114 according to a method such as, e.g., described with reference to the method 500 of FIG. 5 and the method 600 of FIG. 6A.

At step 1701, in response to the controller 118 being initiated to determine dead space at a wound site 114 (such as, e.g., at step 506 of the method 500 of FIG. 5 ), the controller 118 may initiate communication with the tubeset module 300 to confirm that the instillation tubing valve 109 and vent valve 113 b of the calibrated leak system 113 are closed, and that the tubing valve 111 is opened. If the instillation tubing valve 109 and/or vent valve 113 b are open, the controller 118 may instruct the tubeset module 300 to effectuate actuation of the instillation tubing valve 109 and/or vent valve 113 b into a closed configuration. Similarly, if the tubing valve 111 is detected by the controller 118 as being closed, the controller 118 may transmit instructions to the tubing valve 111 via the communications interface 302 to actuate opening of the tubing valve 111.

Once the controller 118 has received, via the communications interface 302, confirmation that the instillation tubing valve 109 and vent valve 113 b are closed and the tubing valve 111 is open, the controller 118 may be configured to initiate operation of the pneumatic pump 120 to apply negative pressure to the negative pressure circuit 200 (such as, e.g., described with reference to step 604 of the method 600 of FIG. 6A). During operation of the pneumatic pump 120, the controller 118 at step 1703 may be configured to receive from the pressure sensor 115 a and/or pressure sensor 115 b pressure readings corresponding to the pressure within the negative pressure circuit 200. As will be understood, the pressure readings received by the controller 118 at step 1703 may be received continuously, at predetermined intervals, and/or in response to specific requests for pressure readings transmitted by the controller 118 to the tubeset module 300 via communications interface 302.

In response to receiving pressure readings from the tubeset module 300 indicative of the pressure within the negative pressure circuit 200 having reached a threshold pressure, the controller 118 at step 1705 may be configured to stop operation of the pneumatic pump 120 and transmit to the tubeset module 300 an actuation signal configured to cause the opening of the vent valve 113 b.

At step 1707, the controller 118 may be configured to receive from the pressure sensor 115 a and/or pressure sensor 115 b pressure readings corresponding to pressure decay within the negative pressure circuit 200, such as, e.g., described with reference to step 606 of FIG. 6A. The pressure readings received by the controller 118 at step 1707 may be received continuously, at predetermined intervals, or in response to specific requests for pressure readings transmitted by the controller 118 to the tubeset module 300 via communications interface 302.

Once the controller 118 has received pressure readings from the tubeset module 300 indicative of the pressure within the negative pressure circuit 200 having reach a threshold pressure (such as, e.g., ambient pressure), the controller 118 at step 1709 may be configured to effectuate, using the tubeset module 300, the actuation of the closing of the tubing valve 111 and the vent valve 113 b in advance of the application of negative pressure to the resultant removed fluid canister circuit 202 (such as, e.g., during step 608 of the method 600 of FIG. 6A).

At step 1711, the controller 118 once again may be configured to receive pressure readings from the tubeset module 300. The pressure readings received by the controller 118 at step 1711 may be received continuously, at predetermined intervals, or in response to specific requests for pressure readings transmitted by the controller 118 to the tubeset module 300 via communications interface 302. In response to receiving pressure readings from the tubeset module 300 indicative of the pressure within the removed fluid canister circuit 202 having reached a threshold pressure, the controller 118 at step 1713 may be configured to stop operation of the pneumatic pump 120 and transmit to the tubeset module 300 an actuation signal configured to cause the opening of the vent valve 113 b.

At step 1715, the controller 118 may be configured to receive from the pressure sensor 115 a pressure readings corresponding to pressure decay within the removed fluid canister circuit 202, such as, e.g., described with reference to step 610 of FIG. 6A. The pressure readings received by the controller 118 at step 1715 may be received continuously, at predetermined intervals, or in response to specific requests for pressure readings transmitted by the controller 118 to the tubeset module 300 via communications interface 302.

According to some embodiments, following step 1715, at step 1717, the controller 118 may be configured to actuate, using the tubeset module 300, the opening of the instillation tubing valve 109, in advance of the instillation of instillation fluid to the wound site 114 (such as, e.g., described with reference to step 516 of the method 500 of FIG. 5 and/or step 622 of the method 600 of FIG. 6A).

CONFIGURATION OF EXEMPLARY EMBODIMENTS

The construction and arrangement of the systems and methods as shown in the various exemplary embodiments are illustrative only. Although only a few embodiments have been described in detail in this disclosure, many modifications are possible (e.g., variations in sizes, dimensions, structures, shapes and proportions of the various elements, values of parameters, mounting arrangements, use of materials, colors, orientations, etc.). For example, the position of elements can be reversed or otherwise varied and the nature or number of discrete elements or positions can be altered or varied. Accordingly, all such modifications are intended to be included within the scope of the present disclosure. The order or sequence of any process or method steps can be varied or re-sequenced according to alternative embodiments. Other substitutions, modifications, changes, and omissions can be made in the design, operating conditions and arrangement of the exemplary embodiments without departing from the scope of the present disclosure.

The present disclosure contemplates methods, systems and program products on any machine-readable media for accomplishing various operations. The embodiments of the present disclosure can be implemented using existing computer processors, or by a special purpose computer processor for an appropriate system, incorporated for this or another purpose, or by a hardwired system. Embodiments within the scope of the present disclosure include program products comprising machine-readable media for carrying or having machine-executable instructions or data structures stored thereon. Such machine-readable media can be any available media that can be accessed by a general purpose or special purpose computer or other machine with a processor. By way of example, such machine-readable media can comprise RAM, ROM, EPROM, EEPROM, CD-ROM or other optical disk storage, magnetic disk storage or other magnetic storage devices, or any other medium which can be used to carry or store desired program code in the form of machine-executable instructions or data structures and which can be accessed by a general purpose or special purpose computer or other machine with a processor. Combinations of the above are also included within the scope of machine-readable media. Machine-executable instructions include, for example, instructions and data which cause a general purpose computer, special purpose computer, or special purpose processing machines to perform a certain function or group of functions.

Although the figures show a specific order of method steps, the order of the steps may differ from what is depicted. Also two or more steps can be performed concurrently or with partial concurrence. Such variation will depend on the software and hardware systems chosen and on designer choice. All such variations are within the scope of the disclosure. Likewise, software implementations could be accomplished with standard programming techniques with rule based logic and other logic to accomplish the various connection steps, processing steps, comparison steps and decision steps. 

We claim:
 1. A wound therapy system, comprising: a therapy device comprising: a removed fluid canister configured to collect wound exudate from a wound; a pump fluidly coupled to the removed fluid canister and configured to draw a negative pressure within the removed fluid canister; an instillation fluid canister configured to store instillation fluid, the instillation fluid canister configured to be fluidly coupled to the wound; and an instillation pump fluidly coupled to the instillation fluid canister and configured to deliver instillation fluid to the wound; tubing attached to and fluidly coupled to the removed fluid canister, the tubing and the removed fluid canister defining a negative pressure circuit; and a tubeset module in fluid communication with the removed fluid canister and the tubing, the tubeset module comprising: a valve configured to selectively permit flow within the tubing when in an open configuration and to selectively block flow when in a closed configuration; a calibrated leak configured to provide fluid communication at a predetermined rate between a negative pressure circuit defined by the tubing and the removed fluid canister and an ambient atmosphere, the calibrated leak comprising: a vent formed through an outer wall of the tubing, a vent valve fluidly coupled to the vent and configured to selectively close the vent; and a flow detector fluidly coupled to the vent and configured to measure flow through the vent; a controller; and a communications interface configured to receive communications from the the controller; wherein the controller is configured to, actuate the valve to the closed configuration in response to a first communication being received by the tubeset module via the communications interface; determine a dead space of the wound; determine a maximum amount of the instillation fluid to be delivered to the wound based on the dead space of the wound; determine a dead space of the removed fluid canister; compare the maximum amount of instillation fluid to be delivered to the wound to the dead space of the removed fluid canister; and actuate an alarm if the maximum amount of the instillation fluid to be delivered to the wound exceeds the dead space of the removed fluid canister.
 2. The system of claim 1, wherein the valve is configured to be actuated to the open configuration in response to a second communication being received by the tubeset module.
 3. The system of claim 2, wherein the communications interface is configured to receive communications wirelessly from the controller.
 4. The system of claim 1, wherein the calibrated leak is configured to selectively provide fluid communication between the negative pressure circuit and the ambient atmosphere in a first configuration and to block fluid communication between the negative pressure circuit and the ambient atmosphere in a second configuration.
 5. The system of claim 4, wherein the calibrated leak is configured to be actuated to the first configuration in response to a third communication being received by the tubeset module.
 6. The system of claim 5, wherein the tubeset module further includes a pressure sensor configured to detect a pressure within the negative pressure circuit.
 7. The system of claim 6, wherein the communication interface is configured to transmit information related to the pressure detected by the pressure sensor to the controller.
 8. The system of claim 7, wherein the first communication is transmitted by the controller in response to the controller receiving the information related to the pressure detected by the pressure sensor from the communications interface.
 9. The system of claim 1, wherein the tubeset module is defined by a plurality of housing elements, each of the valve and the calibrated leak being contained within a separate, distinct housing element. 